Selective Image Guided Resection of Axillary Lymph Nodes

Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their
doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be
asked to sign a separate consent form that describes the chemotherapy and its risks.

On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has
received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of
any abnormal lymph nodes either right before or during their standard breast and underarm
surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard
techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA,
the area is numbed with anesthetic and a needle is inserted into the affected area so that
cells can be collected. Ultrasound imaging is used to guide the needle into the area. The
cells will be used for research to learn if the chemotherapy killed the abnormal lymph node
cells.

Patient will have standard breast and underarm surgery (underarm lymph node removal and
either a partial mastectomy or total mastectomy with or without reconstruction). Patient's
doctor will discuss the surgery with patient in more detail and patient will be asked to
sign a separate consent form.

During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be
removed and sent as separate samples before the rest of the underarm lymph nodes are
removed.

Patient's study participation will be complete after surgery.

This is an investigational study. The surgery in this study is standard treatment. It is
investigational to remove the abnormal lymph nodes before the rest of the underarm lymph
nodes are removed. In this study, the exact same number of lymph nodes would be removed as
is standard, but the surgery is being done in a 2-step process.

Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Greater than or equal to 18 years old.

2. Histologic diagnosis of invasive breast cancer, clinical stage T0-3 N1 (maximum one
or two abnormal axillary nodes on ultrasound exam) M0.

3. FNA biopsy (or core needle biopsy) of an axillary node documenting nodal disease at
time of diagnosis and prior to preoperative chemotherapy or surgery.

4. Marker clip placed in the one or two abnormal axillary nodes identified at
ultrasound.

Exclusion Criteria:

1) Prior axillary lymph node surgery for pathological confirmation of axillary status.